An interventional study of single intravenous (IV) bolus dose of tranexamic acid (TXA) at 15 mg/kg (maximum dose 1000 mg) and Control (Normal saline) in Perioperative Bleeding During Recurrent Hypospadias Repair, sponsored by Aswan University Hospital. Active, not recruiting at 1 site in Egypt. Open to male participants aged 1 Year to 10 Years. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Aswan University Hospital · Not applicable, Interventional, and Treatment
This study aims to fill that gap by evaluating the efficacy and safety of intravenous TXA in children undergoing redo hypospadias surgery, potentially establishing a new standard of care
Male children aged 1 year to 10 years Scheduled for surgical repair of recurrent hypospadias Classified as ASA physical status I or II.
Exclusion Criteria:
Known personal or family history of bleeding disorders or thrombophilia. Documented history of seizures or epilepsy. Known allergy or hypersensitivity to tranexamic acid. Concurrent use of anticoagulant medications or other antifibrinolytics. Significant renal impairment (eGFR \< 60 mL/min/1.73m²).
Participants in the control group will receive an equivalent volume (20cc) of 0.9% normal saline solution, prepared in an identical syringe by the pharmacy
Drug: Control (Normal saline)
single intravenous (IV) bolus dose of tranexamic acid (TXA) at 15 mg/kg (maximum dose 1000 mg)
Drug: single intravenous (IV) bolus dose of tranexamic acid (TXA) at 15 mg/kg (maximum dose 1000 mg)
single intravenous (IV) bolus dose of tranexamic acid (TXA) at 15 mg/kg (maximum dose 1000 mg)
Participants in the control group will receive an equivalent volume (20cc) of 0.9% normal saline solution, prepared in an identical syringe by the pharmacy. It will be administered intravenously in the same manner and over the same duration as the intervention drug to maintain blinding.
Total intraoperative blood loss
This will be quantified using the gravimetric method. All surgical sponges and gauzes will be weighed before use and after being soaked with blood. The difference in weight (1 gram = 1 mL of blood) will be summed to calculate the total blood loss. Suctioned fluids will be measured, and the amount of irrigation fluid used will be subtracted to determine the volume of blood loss collected via suction.
Time frame: INTRAOPERATIVE
Surgical field visibility
Assessed intraoperatively by the primary surgeon at predefined intervals using the Fromme scale (also known as the Boezaart scale), a validated 5-point scale ranging from 0 (no bleeding) to 4 (severe bleeding, surgery not possible).
Time frame: INTRAOPERATIVE
Surgeon satisfaction with the surgical field visibility
To be assessed post- operatively using a 5-point Likert scale (1=Very Dissatisfied, 2=Dissatisfied, 3=Neutral, 4=Satisfied, 5=Very Satisfied).
Time frame: INTRAOPERATIVE
Total operative time
Measured in minutes from the time of skin incision to the application of the final dressing.
Time frame: INTRAOPERATIVE
Incidence of postoperative bleeding complications
Defined as the occurrence of a clinically significant hematoma (requiring drainage or causing wound compromise) or other bleeding event requiring intervention within 7 days of surgery.
Time frame: within 7 days of surgery.
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Plan to share: No
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Aswan University Hospital